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FDA to hold biosimilars hearing

The US Food and Drug Administration will hold a public hearing to garner input on the Biologics Price Competition and Innovation (BPCI) Act of 2009

The US Food and Drug Administration (FDA) has announced that it will hold a two-day public hearing early next month to garner input on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009, the legislation that is intended to create a regulatory pathway for abbreviated approvals of generic biological products.

The hearing, which will take place November 2-3 on the FDA's White Oak Campus in Silver Spring, Maryland, is an opportunity for the federal agency to hear testimony from "the public, healthcare professionals, healthcare institutions, manufacturers of biomedical products, industry and professional associations, patients and patient associations, third-party payers, and current and prospective Biological License Application and new drug application holders," according to the announcement.

The BPCI Act, which is part of the healthcare reform package that was signed into law by President Barack Obama earlier this year, will create an abbreviated approval pathway for biosimilars along the lines of the application process that exists for generic drugs, which allows generic manufacturers to rely on data that has already been gathered about a drug rather than duplicating trials. Biosimilars are defined as biological products that are demonstrated to be highly similar to, or interchangeable with, an FDA-licensed biological product.

The FDA said it is particularly interested in hearing comments about what factors the agency should consider in determining whether a biologic product is highly similar to or interchangeable with the original reference product; what range of differences between products is acceptable; and when the agency should require the sponsor of the biosimilar product to conduct its own animal or human trials, among other issues. The agency is also seeking input on the development of pharmacovigilance programs to ensure the safety of patients who are administered biosimilars.

Interested parties who are unable to attend the hearing in person can submit written comments to the agency.

4th October 2010

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